Kornimate/medical-research-clean huggingface dataset:
16 week efficacy and 2 year long term safety and efficacy of secukinumab in patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to nsaids, dmards and / or tnfα inhibitor therapy.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female patients at least 18 years of age * diagnosis of moderate to severe as with prior documented radiologic evidence (x-ray) fulfilling the modified new york criteria for as (1984) * patients should have been on nsaids with an inadequate response * patients who are regularly taking nsaids as part of their as therapy are required to be on a stable dose * patients who have been on an anti-tnfα agent (not more than one) must have experienced an inadequate response exclusion criteria: * chest x-ray with evidence of ongoing infectious or malignant process * patients with total ankylosis of the spine * patients previously treated with any biological immunomodulating agents except for those targeting tnfα * previous treatment with any cell-depleting therapies * other protocol-defined inclusion/exclusion criteria may apply

Keywords: ankylosing spondylitis as asas inflammatory back pain
circulating tumor dna monitoring in breast cancer undergoing neoadjuvant therapy

Conditions: Stage I-III Breast Cancer

Summary: in the prospective, open, observational study, we aim to evaluate whether circulating tumor dna (ctdna) can be the marker of the response to neoadjuvant therapy in stage i-iii breast cancer.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years-old at the time of consent to participate this trial * patients with stage i-iii invasive breast cancer * no prior anti-cancer treatment * felt to be a possible candidate for neoadjuvant therapy by their physician exclusion criteria: * known to have other aggressive malignant tumor in the past 5 years. * breast cancer during lactation; inflammatory breast cancer; acute inflammatory disease, pregnancy and other conditions may affect the levels of ctdna and/or peripheral inflammatory indicators. * there are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * the investigator determines that subjects are not appropriate to participate in the study due to other factors.
a single centre, prospective, observational study to assess the use of the rehabilitation tool, gripable, in patients with upper limb spasticity receiving botulinum toxin-a (bont-a) in the united kingdom (uk).

Conditions: Upper Limb Spasticity (ULS)

Summary: the purpose of this study is to explore how a rehabilitation tool (gripable) could be used to monitor the effect of bont-a during an injection cycle and understand its potential value as a home rehabilitation tool in routine practice.


Eligibility criteria:
inclusion criteria: * patients with hemiparesis with spasticity in the primary target muscle group (ptmg) for whom a decision to treat with bont-a has been made prior to inclusion in the study * bont-a injection must be administered in the ptmg; injection into additional upper limb muscles must be based on investigator's judgment in line with the relevant summary of product characteristics (smpc) * naïve or non-naïve to bont-a treatment; if non-naïve, at least 4months elapsed after the last bont-a injection, of any marketed formulation prescribed in accordance to the relevant smpc * must be able to use the gripable tool and have access to the internet through wireless connection in the home setting * patients for whom the use of the gripable tool aims to train: 1. wrist extension, 2. supination, 3. grip and release exclusion criteria: * surgery on any upper limb or intrathecal baclofen therapy (itb) for spasticity within the last 3 months * progressive neurological (e.g. parkinson's disease) * patients with no active muscle recruitment in the affected upper limb * patients with significant cognitive impairment
evaluation of ridge dimensional changes after immediate implantation and efficacy of this procedure

Conditions: Atrophy of Edentulous Alveolar Ridge; Alveolar Ridge Augmentation

Summary: 1. evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation 2. evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

24 hopeless single root teeth will be selected. the horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with dfdba. horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and cbct , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent cejs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery. the vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ). the primary and secondary stability will be measured using osstell at baseline and 3-month later. twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. all the measurement will be assessed using caliper and cbct at the time of extraction and 3-month later at the time of implant insertion.

Eligibility criteria:
inclusion criteria: * patients with hopeless single root tooth and willing for dental implants * having no systemic disease exclusion criteria: * fail to osseointegrate

Keywords: atrophy of edentulous alveolar ridge dental prosthesis, implant-supported dental implants, single-tooth
stress reduction program based on mindfulness for patients with discopathies

Conditions: Back Pain

Summary: this study evaluates the influence of stress on inflammation and the symptomatology of the patient with back pain. mindfulness based stress reduction (mbsr) will be used in half of participants, a validated psychopedagogical intervention for stress reduction, and the participants assigned to the control group will follow the usual treatment, according to their diagnosis.

the mindfulness based stress reduction (mbsr) is a psycho-educational program of stress reduction based on mindfulness. it consists of a program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between the week 6 and 7 of the program with a duration of 7.5 hours. each week, the theoretical contents that are necessary to understand the attention development practices will be covered. in addition, basic concepts of the psychobiology and psychology of stress and pain will be explained. the subjects will have a homework load of approximately 45 minutes per day during the intervention program.

Eligibility criteria:
inclusion criteria: * to be diagnosed with symptomatic disc disease (participants must provide a medical report that certifies the discopathy). * normal or moderate mobility * normal cognitive state * patients who have previously read and signed the informed consent. * patients that are capable and willing to comply with the study procedures. exclusion criteria: * serious psychopathologies * suicidal thoughts. * deep depression * psychosis * drug addiction * very limited functional capacity and cognitive impairment: patientsconfined in a bed or a chair. they need the help of a third person. * do not incorporate during the program any clinical, psychological or pharmacological treatments different from those ones that are normally used to controlled the pain, or any drastic changes in lifestyle.
pain and visual outcome in intravitreal bevacizumab injection

Conditions: Diabetic Macular Edema

Summary: in this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. those with the history of ocular pain prior to the procedure, any contraindication for intravitreal bevacizumab injection (ivi), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (vas) are excluded from the study. before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (bcva) checking and macular thickness measurements using optical coherence tomography (oct). patients are randomly assigned to each group .each participant receive one injection in one eye in this study. pain is measured by subjective grading on a visual analog scale (vas) immediately after ivi. bcva and oct would be checked again at month one.


Eligibility criteria:
inclusion criteria: * diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions exclusion criteria: * history of ocular pain prior to the procedure, any contraindication for intravitreal bevacizumab injection (ivi), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (vas)
optimum platelet inhibition after coronary bypass surgery

Conditions: Ischemic Heart Disease

Summary: to investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.


Eligibility criteria:
inclusion criteria: we intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent. exclusion criteria: preoperative exclusion criteria: * patients who are have not stopped aspirin 7 days prior to surgery * patients on concomitant nsaids * patients with a previous history platelet disorders, splenectomy or haematological disorders * patients with aspirin induced asthma * patients with any contraindications to aspirin (gi bleed) * patients who are on any medication that may result in a serious drug interaction with aspirin (warfarin) * women of childbearing potential * patients of less than 18 years * if informed consent cannot be obtained * if for any reason the consultant surgeon or anaesthetist deems it to be appropriate operative exclusion criteria: • concomitant procedures postoperative exclusion criteria: * patients who receive platelet transfusion * patients who receive nsaids * requirement for intra aortic balloon pump support * failure of extubation within 24 hours
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for oa

Conditions: Osteoarthritis; Spinal Arthritis

Summary: this trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of osteoarthritis.

studies have shown that stem cell treatment is safe and efficacious for the treatment of osteoarthritis (oa). this patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of oa. patients with oa will receive intravenous infusion and intraarticular injection of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of osteoarthritis * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: osteoarthritis stem cell treatment spinal arthritis
individual patient expanded access ind of autologous hb-admscs for the treatment of systemic lupus erythematosus (sle)

Conditions: System; Lupus Erythematosus

Summary: this protocol is part of an fda individual patient expanded access ind. this study is to be conducted according to us and international standards of good clinical practice (fda title 21 part 312 and international conference on harmonization guidelines), applicable government regulations and hope biosciences stem cell research foundation policies and procedures.

this individual patient expanded access ind has been created per the request of a 65-year-old woman diagnosed with systemic lupus erythematosus (sle).

Eligibility criteria:
inclusion criteria: * adult individual 18 years of age or older. * cognitively intact and capable of giving informed consent. * clinical diagnosis of systemic lupus erythematosus. * subject has mesenchymal stem cells banked at hope biosciences. * the patient accepts to receive treatment and to comply with follow-up visits. exclusion criteria: * clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine diseases that in the opinion of the investigator may increase the risks associated with study participation. * active alcohol or drug addiction. * participation in concurrent interventional research studies during this study. * severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history. * unwillingness to return for follow-up visits.
a multicenter study of noninvasive neuromodulation treatment for subjective tinnitus

Conditions: Subjective Tinnitus

Summary: the purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. this study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. the complete data included pure tone audiometry, tinnitus assessment, mood assessments, and sleep quality assessment. paired t-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.

the purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. this study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. the complete data included pure tone audiometry, tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analog scales), mood assessments (hamilton anxiety scale, hamilton depression scale), and sleep quality assessment (pittsburgh sleep index scale). paired t-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.

Eligibility criteria:
inclusion criteria: * ≥18yrs, * diagnosed as subjective tinnitus, * thi≥38, * chinese, can cooperate with all chinese version evaluation, * right-handed, * no major neurological disease or other exclusion criteria: * hyperacustic, * incomplete case data

Keywords: non-invasive neuromodulation subjective tinnitus clinical effect sleep quality anxiety depression
discontinuation or continuation of immunosuppressive therapy in participants with chronic graft versus host disease

Conditions: Chronic Graft Versus Host Disease

Summary: this randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.

primary objective: i. assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (gvhd) to discontinuation (standard of care) versus continuation (investigation) of immunosuppressive therapy (ist). secondary objectives: i. assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients. ii. assess whether prolonged ist decreases the need for pulses of high dose ist. iii. evaluate the effect of prolonged ist on chronic gvhd manifestations and severity, risk of relapse, infection and organ toxicity. outline: participants are randomized to 1 of 2 arms. arm i: participants have their ist tapered and discontinued per the plan. arm ii: participants continue to receive a fixed dose ist for an additional 9 months with no taper. after completion of study treatment, participants are followed up annually.

Eligibility criteria:
inclusion criteria: * prior first allogeneic stem cell transplant, with any graft source, donor type, and gvhd prophylaxis * patients who are on one systemic immunosuppressive agent for chronic gvhd with a plan to withdraw all systemic ist; hydrocortisone or prednisone continued for treatment of adrenal insufficiency is not considered a systemic ist * no evidence of malignancy at the time of enrollment * agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization * agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years * signed, informed consent exclusion criteria: * inability to comply with study procedures * pregancy
comparison of self-fixating vs non-fixating hernia mesh

Conditions: Inguinal Hernia

Summary: the purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

this is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a totally extraperitoneal (tep) fashion.

Eligibility criteria:
inclusion criteria: * \> 18 years * asa classification i, ii, iii * scheduled for elective tep inguinal hernia repair exclusion criteria: * asa classification iv or greater * needing emergency surgery * known history of narcotic dependence * undergoing bilateral inguinal or combined umbilical hernia repair * undergoing other procedures during same anesthetic * undergoing recurrent inguinal hernia repair
periodontal treatment and metabolic control in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus; Periodontal Disease

Summary: the studies that correlate periodontal disease (pd) and diabetes mellitus (dm) suggest that individuals with poor glycemic control are at increased risk for developing infections. despite being controlled for other important risk factors, diabetic patients are three times more likely to develop pd, and therefore, periodontitis has been proposed as the sixth complication of dm. besides the effect of diabetes on dp, the reverse has also been studied over the past 15 years, through the idea that chronic and acute infections can directly affect the tissue resistance to insulin. recent studies have provided evidence that controlling periodontal infection has an impact on improvement of glycemic control in diabetes mellitus patients. the vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory mediators, pathogenic bacteria and their products into the bloodstream. some researchers have suggested that periodontal treatment in type 2 diabetes mellitus (dmt2) patients, results in beneficial effect on the level of glycemic control. however, there is no conclusive evidence to support this hypothesis. this research project aims to determinate the impact of periodontal therapy on metabolic control in dmt2 individuals, and determinate the possible association between periodontal disease and dmt2. for the hba1c outcome this clinical trial had a sample size calculation estimated at 120 patients. for the inflammatory serum markers this study had a sample size estimated at 22 individuals. blood samples will be collected for evaluation of hba1c and inflammatory serum markers. this data will highlight the possible role of periodontal therapy on dmt2 metabolic control.


Eligibility criteria:
inclusion criteria: * subject aged over 30 years old * subject diagnosed with t2dm * subject consenting to the study * subject with signs of severe periodontitis (at least 50 periodontal pockets, ppd \> 4mm and bleeding on probing) exclusion criteria: * pregnancy - lactation * subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit * subject with known hiv or hepatitis (b, c) * subjects with uncontrolled systemic diseases (cardiovascular diseases including hypertension, liver, pulmonary diseases, end stage renal failure) and/or neoplasm * subjects not capable to provide informed consent * subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures

Keywords: type 2 diabetes mellitus periodontal disease metabolic control periodontal treatment inflammatory markers
comparing long term outcomes in chronic stroke survivors across investigational assessments following a prescribed upper extremity exercise program

Conditions: Chronic Stroke

Summary: the purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.


Eligibility criteria:
inclusion criteria: * single qualifying stroke event as confirmed by ct or mri * at least 1 month post stroke * score of at least 2-/5 on manual muscle test for wrist flexors or extensors, indicating adequate movement to complete robotic device use * able to follow written instructions exclusion criteria: * prior arm injury impacting available passive or active range of motion or significant arm pain with movement * underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc. * prior significant drug or alcohol abuse * diagnosed with dementia * pre-stroke baseline modified rankin scale (mrs) \>3 * history of seizure/epilepsy * history of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness. * pregnancy * contraindication to mri or transcranial magnetic stimulation (tms). * medical instability assessed by the treating stroke physician to participate to the study.

Keywords: chronic stroke stroke arm impairment